boron neutron capture therapy using boronophenylalanine-fructose complex in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: boron neutron capture therapy using boronophenylalanine-fructose complex may kill tumor cells without harming normal tissue. purpose: this phase ii trial is studying how well boron neutron capture therapy using boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.

objectives: primary * determine the therapeutic activity and efficacy of boron neutron capture therapy using boronophenylalanine-fructose complex in patients with metastatic melanoma. * determine the objective local response in patients treated with this regimen. secondary * determine the overall survival of patients treated with this regimen. * determine the duration of local response and time to local progression in patients treated with this regimen. * determine the dose-response relationship at the per-lesion level in patients treated with this regimen. * determine the safety of this regimen in these patients. * determine the toxicity of this regimen in these patients. outline: this is an open-label study. patients receive boronophenylalanine-fructose complex iv over 90 minutes followed by boron neutron capture therapy on days 1 and 2. patients are followed at 1 and 6 weeks and then every 8 weeks thereafter. in the event of disease progression, patients are followed every 3 months for survival. projected accrual: a total of 16-24 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed melanoma * metastatic disease * brain metastases, skin metastases, or soft tissue metastases of the head and neck or the extremities * accessible lesion(s) for boron neutron capture therapy (bnct) * no clear progression of disease at other sites than the ones intended for treatment with surgery and/or bnct * measurable disease by mri within the past 4 weeks * lesion(s) ≥ 10 mm in diameter * indication for palliative radiotherapy that is intended to be delivered as bnct patient characteristics: age * 18 and over performance status * karnofsky 70-100% life expectancy * not specified hematopoietic * neutrophil count ≥ 2,000/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 10 g/dl hepatic * bilirubin ≤ 2.5 times upper limit of normal (uln)\* * transaminases ≤ 2.5 times uln\* * alkaline phosphatase ≤ 2.5 times uln\* note: \*unless due to reversible reaction to antiseizure medication renal * creatinine ≤ 2.5 times uln * blood urea nitrogen ≤ 2.5 times uln cardiovascular * no congestive heart failure * no newly diagnosed or unstable angina pectoris * no uncontrolled arrhythmias * no uncontrolled conduction defects * no recent coronary artery disease * no other severe heart disease pulmonary * no severe pulmonary disease, including severe obstructive or restrictive lung disease other * no history of phenylketonuria * no severe gastrointestinal disease * no active peptic ulcer disease * no uncontrolled endocrine disease * no pre-existing serious mental or organic brain disease (e.g., epilepsy) * no psychological, familial, sociological, or geographical condition that would preclude study compliance * able to travel to the netherlands via public transportation * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * no concurrent immunologic or biologic therapy * no concurrent colony-stimulating factors (e.g., epoetin alfa or filgrastim \[g-csf\]) chemotherapy * no concurrent chemotherapy endocrine therapy * no concurrent hormonal therapy radiotherapy * no prior radiotherapy to site(s) proposed for study treatment * no other concurrent radiotherapy surgery * see disease characteristics other * recovered from all prior anti-tumor therapy (excluding alopecia and sensitive peripheral neuropathy ≤ grade 2) * no other concurrent anticancer therapy * no other concurrent investigational drugs

Keywords: stage iv melanoma recurrent melanoma